NDC 0004-0191

Boniva

Ibandronate Sodium

Boniva is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Ibandronate Sodium.

Product ID0004-0191_20b76315-bc0f-40d2-b877-a1df6e3e2461
NDC0004-0191
Product TypeHuman Prescription Drug
Proprietary NameBoniva
Generic NameIbandronate Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-01-06
Marketing CategoryNDA / NDA
Application NumberNDA021858
Labeler NameGenentech, Inc.
Substance NameIBANDRONATE SODIUM
Active Ingredient Strength3 mg/3mL
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0004-0191-09

1 SYRINGE, GLASS in 1 CARTON (0004-0191-09) > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2006-01-06
Marketing End Date2021-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-0191-09 [00004019109]

Boniva INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021858
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-01-06

Drug Details

Active Ingredients

IngredientStrength
IBANDRONATE SODIUM3 mg/3mL

OpenFDA Data

SPL SET ID:5500be0f-8b29-450c-9857-755029965157
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904952
  • 904954

    • Pharmacological Class

    • Bisphosphonate [EPC]
    • Diphosphonates [CS]

    NDC Crossover Matching brand name "Boniva" or generic name "Ibandronate Sodium"

    NDCBrand NameGeneric Name
    0004-0186Bonivaibandronate sodium
    0004-0191Bonivaibandronate sodium
    23155-162Ibandronate sodiumIbandronate sodium
    25021-827ibandronate sodiumibandronate sodium
    33342-150IBANDRONATE SODIUMIBANDRONATE SODIUM
    47781-103IBANDRONATE SODIUMIBANDRONATE SODIUM
    51224-008IBANDRONATE SODIUMIbandronate Sodium
    55111-575Ibandronate sodiumIbandronate sodium
    55150-191Ibandronate SodiumIbandronate Sodium
    60429-643IBANDRONATE SODIUMIBANDRONATE SODIUM
    60505-2795IBANDRONATE SODIUMIBANDRONATE SODIUM
    60505-6097Ibandronate Sodiumibandronate sodium
    62756-218IBANDRONATE SODIUMIBANDRONATE SODIUM
    65862-237Ibandronate SodiumIbandronate Sodium
    67457-524ibandronate sodiumibandronate sodium

    Trademark Results [Boniva]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BONIVA
    BONIVA
    78404853 not registered Dead/Abandoned
    Roche Therapeutics Inc.
    2004-04-20
    BONIVA
    BONIVA
    78392767 not registered Dead/Abandoned
    Boniva Software, Inc.
    2004-03-29
    BONIVA
    BONIVA
    78209524 2931724 Live/Registered
    Roche Therapeutics Inc.
    2003-01-31
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